GCP Consultant, GCP Auditor
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Portugal
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About the role
- Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines
- Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).
- Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
- Assisting with business development activities
Requirements
- BSc in Life Science preferred
- Experience in conducting and leading internal and external GCP audits for a variety of stakeholders
- Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I)
- Experience in conducting GCP systems audits.
- Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site.
- Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage.
- Expert knowledge of national and international GCP legislation and guidelines.
- Up to 40% travel and ability to conduct remote audits.
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCP auditsquality assuranceservice provider auditsGCP systems auditsinspection preparationmock inspectionsregulatory requirementsdata managementbiostatisticspharmaceutical industry
Soft Skills
business developmentcoordinationmanagementcommunicationleadership